African indigenous medicine: Its standardization and evaluation within the policy of primary health care

M. KOUMARE

WHO Africa Office
Brazaville, Republic of Congo

ABSTRACT

The indigenous African remedy obeys some rules of preparation which respect and allow the obtention of acceptably standardized products, qualitatively and quantitatively.

The study of therapeutic dosages used by traditional health practitioners shows that these dosages are also acceptable.

The effectiveness of therapy studied by clinical tests as well as the importance of the accomplishment of indigenous remedy, both constitute the elements for their evaluation.

The rules of this evaluation are expected to take account of the concept of African indigenty.

Introduction

There is no doubt today that Primary Health Care (PHC) offers one of the most viable approaches for attaining accessibility to health for all. In fact, this approach takes into account all appropriate resources available, including the practices and remedies in the indigenous system of care. The pharmaceutical component of this policy of Primary Health Care, requires the provision of appropriate medicines to the populations, taking into account both geographical and economical factors.

In spite of the popularity of the African indigenous medicine, its acceptability is still viewed with certain distrust. Hence the necessity of its evaluation and its standardization in order to enable it to be confirmed and to be registered on the list of essential medicines.

Although everybody is unanimous on the necessity of an evaluation, not everybody is in favour of the conditions which are currently applied in putting new medicines on the market. Our purpose is not really to bid acceptance of whatever medicine for Primary Health Care, nor again to match the African indigenous medicine with the European medicine; but rather to present an experience, whose aim is to dispel the distrust that has been caused by negative prejudices and to assist in solving the problem of public health, which is the regular destination of sanitary training programmes in medicine.

Although there is an apparent analogy in the medicinal conceptions of the two systems of health care, namely, the African indigenous and the European exotic system, it is also true that the philosophy that underlies them is different. One is a result of an analytical method of reasoning and of experimentation; and the other is a result of a systematic method of intuition and empiricism.

At first, one could think that the medicines of the European exotic system treat the causes of illness and that those of the African indigenous system deal with the symptoms. We would like to state that it is not just to say that the African indigenous medicines are only used to treat the symptoms.

As we have already stated orally and in writing, each of these systems of treatment has "etiological medicines" as well as "symptomatic medicines" whose application depends on given rules. It has become both necessary and urgent that we should discuss these rules, so as to know the degree to which they are reliable and to allow better standardization of the African indigenous treatment. As such, we have tried to follow the procedures of its elaboration and its administration.

The elaboration of the African indigenous medicine

The distrust, leave alone fear, that we have described above still persists within the African indigenous medicine, in spite of the great involvement of the populations. One cannot deny the fact that this distrust is justified; but, unfortunately, too often and even improperly, we tend to accuse the therapeutical quality and doses of the indigenous medicines. "The false healers" are, unfortunately, too many and it is not possible to guarantee their skills and competence. In fact, we are not denying the insufficiency of the African traditional pharmaceutical art; but it appears to us unjust not to recognize that there exist rules for the preparation and the administration of indigenous medicines well adapted to the system.

In order to be truly convinced, it is sufficient to note that in certain countries, it has been possible to codify the rules of the indigenous medicine in general and that of the indigenous treatment in particular.

Raw materials

We shall limit ourselves, in this study, to medicinal plants which form the major part of the raw materials and whose techniques for collection seem to be well respected, if not standardized.

The strict respect of the rules for collection, arises from the fear that the phytotherapeutist derives his experience from the transgression of these rules. Each gesture is taken into account. We do not share the view of those who always see in its implementation nothing but superstition. Moreover, even if there was an element of superstition, it would be desirable not to be opposed to it before knowing its origin or making its complete evaluation. In the same way, it is important to preserve all the necessary conditions during the collection phase and to obtain average samples of the raw materials that would be easy to test and to confirm. In our opinion, the presentation under the form of bundles easily draws one's attention. We have tried to find out the approximate weight by vegetable species. This homologation, from our modest experience, is more convenient for the phytotherapists than for the herbalists who are much worried about the sales of their products, even when there is an apparent homogeneity of all the bundles.

The identification of plants is not only morphological; it is a real diagnosis which is practised by the phytotherapist from the organoleptic characteristics. Moreover, he knows the period and the place of collection, and the part of the plant which will ensure constant results. Unfortunately, many researchers do not involve themselves with the terrain and do not ask questions sufficiently. It is rare that the phytotherapist will preserve raw materials for a whole year. While for herbalists this is a usual practice.

In our opinion, with the identification made by the phytotherapists, the knowledge of the useful part of the plant, the techniques, period and the favourable place for the collection - all this makes it possible to establish the basis for an acceptable homologation from the average samples.

It is certain that, it is necessary for the institutions which are responsible for the study of medicinal plants, to gradually improve this knowledge by supplementing it with other elements which are normally not part of the traditional health practitioners. It is the method of approach which make us determine the best period for collection, the major chemical groups, the water content, ashes and essential oils, etc. If the traditional medical ethics require the phytotherapist to observe strict respect of some definite rules of collection, it would be advisable to make an adaptation of the preparation and of the treatment of the patient. This practice makes it very difficult to have standardization in any industrial manufacturing of the medicine.

Composition of the medicine

The qualitative and quantitative standardization of the composition of the African indigenous medicine, will prove necessary when it starts being manufactured industrially or even semi-industrially, for, the rules of individual preparations advocated by the traditional therapists might be difficult to apply. It is, however, important that one should not make too many modifications without making a prior indepth analysis as it was recommended when we discussed the techniques for collection.

With regard to the qualitative aspect, it would not be wrong to say that some African indigenous medicines contain more than ten ingredients. Only medicines in the group "excipient" which are normally registered in a special inventory, such as, the "vidal", would contain as many ingredients. This is why it is important, as we have already stated, that we should never consider anything as useless. It is, however, possible, after discussions with the traditional therapist and conducting some chemical, pharmacological and/or clinical tests, to eliminate certain drugs which would not change the acceptability, the harmlessness or the effectiveness of the medicine. This is the essence of our approach.

As far as quantity is concerned, it is sufficient to be guided by the traditional therapist in taking the right measures of each ingredient. These measures, could easily be reproduced later from average quantities which could be established after several measurements.

In order to facilitate the methods of preparation, we started by adopting kitchenware methods which are used by the traditional therapist. Then, gradually as we established the specific values of certain elements, we replaced the kitchenware, with the appropriate pharmacotechnical apparatus. Thus, we ended up by establishing a certain equivalence between the two devices and to facilitate communication and dialogue between health care systems.

States caused by medicine and how these happen

Although it was relatively simple to compare the tenuity of the powder obtained from local kitchen sieves and the powder obtained from our Forplex grinder, it was not the same thing for the other forms of galena. We can, however, state that the strict observance of the methods of operation guarantees, to a certain extent, the reproduceability of the characteristics of preparations and as a result, that of the doses. That is why in the case of a decoction, for example, the traditional therapist will normally put into account the following:

From the qualitative aspect:

· the colour of the decoction
· if no special colour, its viscosity, and
· how it tastes (astringency).

From the quantitative aspect:

· the number of bundles found in the plant, and
· water volume at the beginning and at the end of the operation, often determined by the immersion or non-immersion of the bundles of plants, and state the time taken for boiling up.

The monitoring of this reproduceability could be done by the extraction of dry decocta by denning, both qualitatively and quantitatively, certain properties and characteristics.

With regard to one of the most frequent criticisms, namely, that concerning the hygienic conditions, again we think that it is not just to say that the traditional therapist is not concerned about it. The methods of nitration or decantation, the use of new containers which have never been used, the taking into account of the pharmaceutical forms (especially orally or externally) explain in part the situation.

We are going to provide one of the fundamental principles of the African indigenous medicines for your consideration:

· The human organism needs a symbiotic equilibrium and cannot subsist in an absolute sterility.
· The administration of the African indigenous medicine: the posology

The existence of doses in the African traditional medication has often been questioned. In our opinion, we have sometimes wrongly attributed to medication accidents caused by the imprudence of the victims themselves. The purpose of our discussion here is more to affirm the existence of acceptable therapeutical doses, rather than to deny the insufficiency of precision of the measurement units.

One of our objectives is to have a better knowledge of the rules which determine the dosage so as to improve such rules.

As we have already said, the strict observance of the methods of preparation makes it possible to obtain relatively good quality medicines that are highly appreciated by the traditional therapist and which, in spite of such a moderately equipped institution, are determined with reasonable precision. Thus, without involving ourselves in the active principle, we shall study both qualitatively and quantitatively, certain ingredients (at least two) and certain characteristics (physicochemical and/or organoleptical) in order to prove that the preparations are of good quality.

The existence of non-unitary pharmaceutical forms makes it imperative to know the rules of the measurements used in collecting the medicine as well as the methods used in doing it. It is not sufficient, for example, to use the same spoon and the same product in order to believe that the quantities of the measured powder are the same. In fact, in order to have the same quantity, it is necessary to respect the rule of the base measurement. Moreover, the use of a spoon requires certain precision, such as, whether it is a tea-spoon, a table-spoon or a spoon used for dessert. Also, in traditional practices, it is necessary to know that the pinch by fingers is done vertically and is limited to the first phalanx. It is necessary to indicate the number of fingers to be used or, at least, which of the two fingers will retain the pinch of the medicine.

A well-balanced study of fresh plant material gave us a variation from simple to triple (1:3 to 3:1). The ones of pinches showed a variation of 1 to 2.5 (see Annex).

By way of mouth, the quantity of decocta absorbed by the sick persons, are functional to the capacity of their stomach whose variation limits (1 to 1.5 litres for an adult) enable the traditional therapists to advocate a drink of a certain infusion of herbs.

In taking again the example of the vidal catalogue, we notice that the usual dose for the day for an adult can vary often from 1 to 3 tablets. In other words, the variation is from a single to a triple dose.

A comparison from these various figures, enables us to state, in our opinion, that the variations of the therapeutical doses advocated by the traditional therapist are acceptable.

We think that the decision as to the dose to be administered depends also on the competence of the practitioner; and this is true of both medical systems. It is up to the doctor to adapt this ordinary dose, taken throughout the day, to different cases. It is only his experience which will enable him to avoid the errors of estimation and accident. The attitude of the traditional therapist, as that of a doctor, is determined by the general state of the sick person, as well as other factors such as, sex, age and bodybuild (for the traditional therapist especially), or weight (for the doctor), and the seriousness of the disease.

Evaluation of the African indigenous medicine

Elements of evaluation

The therapeutical efficiency and the importance of the use of the African indigenous medicine constitute, undoubtedly, the elements of its evaluation:

· In fact, there is no need to recall here, the good results of some of the traditional preparations which are based on the discovery of pure crystalline products and the synthesis of similar substances.

· The acquired popularity since decades of use "(estimated pharmacovigilance)" and the high consumption of indigenous medicine, which enable us to establish its importance for pharmaceutical use and to determine whether it should be registered on the list of essential drugs.

The evaluation method, in our opinion, should be to make comparisons (through clinical tests) with an already existing medicine on the market and which enjoys a very good acceptability in all respects, namely, its cost, its effectiveness and its availability.

Prior conditions in the evaluation of the African indigenous medicine

The marketing of any medicine today depends on a number of strict conditions, which, although necessary and indispensable for new molecules, do not seem to us to be justifiable for the indigenous medicine which has successfully undergone the tests of time after its administration on the human species. This means, in fact, that the pharmacovigilance, that is the supervision of the medicinal results in their usual conditions of use, has not been favourable to it. We cannot deny the possibility of teratogenic toxicity of these medicines; but we think also that it is not just to underestimate the fact that they have gone through the test of time after they were administered on people and not on animals in a laboratory. This is why we are advocating that we should adapt administrative and legislative conditions of marketing so as to ensure that they are appropriate and that they facilitate innovation rather than block it. We think that this adaptation should take place by allowing comparative clinical tests to be carried out sooner than it is the case now, at least legally and officially. The issue involved is more ethical than scientific. This is why the solution should be in line with the ethics of our socio-cultural environment.

Conclusion

At the end of this paper, we think that we have succeeded in discussing very clearly our approach, our results and our conclusions, with regard to the standardization and evaluation of the African indigenous medicine. We have shown how it is important to understand the attitudes and concepts, which are the causes of the shortcomings in the practices, in order to find ways of making them reproducible.

We would like to add that this approach is not opposed to any other earlier approach which may have been used in more indepth studies on, for example, the active principle (if this exists at all), its toxicity and its mechanism of action.

Without denying the importance of these studies, our priority was not to look for an active principle or to determine an LD₅₀ value, or a plan of action. But, our priority was rather to ensure that the reproduceability and the stability of the preparations was carried out within certain norms of specifications. For, we are dealing with medicines for which the pharmacovigilance test has not been unfavourable. As such, we think that the establishment of average samples over a given period of collection, and the strict observance of certain rules suffice.

The improved indigenous medicine, as we have called it, can be accepted and produced, at least semi-industrially, so as to respond to the problem of public health which requires the supply of medicines through health education. This can be effected by an adaptation of conditions of marketing that would be in line with the ethics of our socio-cultural environment.

References

Delmas, A. (1970). Anatomic Humaine, Descriptive et Topographique. Masson, Paris.

Kayser, C. (1963). Physiologie: Fonctions de Nutrition. Flammarion, Paris.

Koumare, M. (1978). "Le Remede Traditionnel African et Son Evaluation" in Journal Sante Pour Tous Bamako. Vol. 3: 28-33:

APPENDICES

1. Evaluation of Fresh Plant Bundles (in grams)

No. d'odre	Guiera senegalensis	Diospyros mespiliformis	Saba senegalensis	Opilia celtidifolia	Bridelia ferruginea (saguan)	Parkia biglobosa (nere)
1	110,2	185,5	182	51,5	232,2	181,5
2	140,4	191,8	177,5	130,2	226,1	220,9
3	116,1	224,4	166,4	164	257,2	169,8
4	122,8	149,4	190,9	142,7	194,9	252
5	161,9	184,3	155,1	105,8	206,4	184,2
6	130,7	230,3	138,8	115,8	184	179,2
7	167,6	191,8	177,5	130,4	190,6	136,5
8	113,5	212,5	113,2	140,2	215,7	153,2
9	147,9	212,3	192	136,5	187,6	104,7
10	122	207,9	189,8	94,6	194,1	193,3
11	1333,1	1990,2	1683,2	1211,7	2088,8	1775,3
Average	133,31	199,02	168,32	121,17	208,88	177,53

2. Calculus of the Variations of the Pinch Measurements of Asthmagardenia Powder

Dgnation des ses de mesures	Mesure extra infeure (Mi)	Mesure extreme supeure (Ms)	Report Ms Mi
1	0,2073	0,5278	2,5
2	0,1976	0,3212	1,6
3	0,1966	0,3282	1,6
4	0,2310	0,3443	1,5
5	0,2542	0,3600	1,4

3. Calculus of the Variations of the Fresh Bundle Measurements

Dgnation des plantes	Mesure extreme infeure (mi)	Mesure extreme supeure (me)	Rapport Ms
Guiera senegalensis	110,2	167,6	1,5
Diospyros mespiliformis	149,4	230	31,5
Saba senegalensis	113,2	192	1,6
Opilia celtidifolia	51,5	164	3,1
Bridelia ferruginea	184	257	21,3
Parkia biglobosa	104,7	252	2,4

4. Evaluation of the Pinch of Asthmagardenia Powder

No. d'odre	Tare Tare + Poudre		Poudre (g)
1	5,9558	6,2604	0,3046
2	6,2375	6,5157	0,2782
3	6,4909	6,6982	0,2073
4	5,8706	6,3035	0,4329
5	6,3572	6,7570	0,3998
6	5,7518	6,2796	0,5278
7	6,3614	6,7975	0,4361
8	6,1505	6,5910	0,4405
9	6,1310	6,4805	0,3495
10	6,0659	6,4950	0,4291

My = 0,3805 gm

5. Evaluation of the Pinch of Asthmagardenia Powder

No. d'odre	Tare Tare + Poudre		Poudre (g)
1	6,2980	6,5042	0,2062
2	6,1622	6,4777	0,3155
3	6,7003	6,9084	0,2081
4	6,2670	6,4646	0,1976
5	6,6130	6,9342	0,3212
6	6,1116	6,3390	0,2274
7	6,6522	6,9386	0,2864
8	6,2492	6,5276	0,2784
9	6,2055	6,4426	0,2371
10	5,6594	5,9298	0,2704

My = 0,2548 g

6. Evaluation of the Pinch of Asthmagardenia Powder

No. d'odre	Tare Tare + Poudre		Poudre(g)
1	6,2980	6,5032	0,2052
2	6,1620	6,3862	0,2242
3	6,7005	7,0287	0,3282
4	6,2672	6,5349	0,2677
5	6,6130	6,8559	0,2429
6	6,1113	6,3628	0,2515
7	6,6522	6,8795	0,2273
8	6,2489	6,4455	0,1966
9	6,2058	6,4220	0,2162
10	5,6593	5,8643	0,2050

My = 0,2364 g

7. Evaluation of the Pinch of Asthmagardenia Powder

No. d'ordre	Tare Tare + Poudre		Poudre (g)
1	6,5,9559	6,2130	0,2571
2	6,2381	6,5824	0,3443
3	6,4914	6,7793	0,2879
4	5,8704	6,1430	0,2726
5	6,3573	6,6548	0,2975
6	5,7522	6,0433	0,2911
7	6,3616	6,6746	0,3130
8	6,1508	6,3818	0,2310
9	6,1312	6,4310	0,2998
10	6,0663	6,3322	0,2659

My = 2860 g

8. Evaluation of the Pinch of Asthmagardenia Powder

No. d'odre	Tare Tare + Poudre		Poudre(g)
1	8,8108	9,1197	0,3089
2	6,1620	6,4421	0,2081
3	6,7005	6,9547	0,2542
4	6,2673	6,5570	0,2897
5	6,6130	6,9702	0,3572
6	6,1112	6,4504	0.3392
7	6,6524	6,0124	0,3600
8	6,2493	6,5490	0,2997
9	6,2057	6,5402	0,3345
10	5,6595	5,9712	0,3117

My = 3135 g